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AASLD/IDSA Release Updated HCV Treatment Guidelines

The AASLD and IDSA HCV Guidance Panel has released updated guidelines for the treatment of hepatitis C virus infection, according to newly published data in Hepatology.

“The goal of the hepatitis C guidance is to provide up-to-date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence,” the researchers wrote. “This review provides a condensed summary of recommendations from the guidance.”

The panel, which included HCV Next Editorial board members Arthur Y. Kim, MD, and Michael R. Charlton, MD, and HCV Next Co-Chief Medical Editor Michael S. Saag, MD, used an evidence-based approach to review available information for the HCV guidance. Sources of information included peer-reviewed research; FDA research and safety information on products; manufacturer information; drug interaction data; prescribing information from FDA-approved products; and more.

Key recommendations were outlined in various topics: HCV testing and linkage to care, when and in whom to begin HCV therapy, the initial treatment of HCV, treating unique patient populations, HIV/HCV coinfection and acute HCV.

HCV testing and linkage to care

The panel recommends a one-time HCV test in people born between 1945 and 1965, as well as other people based on exposures, behaviors and conditions that may increase risk for contracting HCV. Every person that is recommended for HCV testing should be tested for anti-HCV using an FDA-approved test, according to the researchers, with positive results being confirmed through nucleic acid testing for HCV RNA. The panel also recommends annual testing be performed on men who have sex with men and people who inject drugs, as these populations are at increased risk.

Who should get HCV treatment and when

The panel recommends antiviral treatment for anyone diagnosed with chronic HCV infection, with the exception of people with limited life expectancy due to “non-hepatic causes.” If resources are limited for the patient to get treatment, the panel deems it “most appropriate to treat those at greatest risk of disease complications before treating those with less advanced disease,” according to the guidelines. To determine those at greatest risk for complications, the panel recommends noninvasive testing or liver biopsy for assessing hepatic fibrosis stage, which determines the urgency for treatment.

Top10 

Initial treatment of HCV

Treatment-naive patients with HCV and different genotypes have posed a challenge. Some of the treatment recommendations from the panel for the various genotypes remained the same, but with the approval of daclatasvir (Daklinza, Bristol-Myers Squibb), the panel recommends its use in certain situations. Daclatasvir at 60 mg in combination with sofosbuvir (Sovaldi, Gilead Sciences) has been added as recommended treatment for for treatment-naive patients with HCV genotype 1a, 1b and 3 for 12 weeks without cirrhosis and 24 weeks in combination with ribavirin in patients with cirrhosis. It is recommended in genotype 2 for 12 weeks in patients without cirrhosis.

Daclatasvir dosing should be adjusted as needed for patients with coinfection who are also receiving cytochrome P450 3A/4 inducers and inhibitors.

Retreating patients who failed prior therapy

The panel recommends various regimens for treating this type of patient population, including ledipasvir/sofosbuvir and simeprevir (Olysio, AbbVie) in combination with sofosbuvir. Treatments vary for patients with different genotypes, with and without cirrhosis, as well as patients who failed prior treatment with PEG-IFN and RBV.

Monitoring patients before, during and after antiviral therapy

The panel recommends all patients with HCV be evaluated prior to starting therapy, during treatment, and following discontinuation of treatment “in order to determine the severity of their liver disease and the efficacy and safety of their HCV treatment,” according to the research. Patients who fail to achieve sustained virologic response should undergo the following: a disease progression assessment every 6 to 12 months; ultrasound testing for HCC every 6 months in patients with advanced fibrosis; endoscopic surveillance in those with cirrhosis; among other recommendations. In patients who achieved SVR, the following is recommended: surveillance for HCC with twice-yearly abdominal imaging in those with fibrosis, patients without advanced fibrosis will no longer need to undergo additional follow-up, undergo an assessment for HCV recurrence or reinfection if the patient experiences some sort of hepatic dysfunction, among other recommendations.

Treating unique patient populations

The panel recommends patients with decompensated cirrhosis be referred to a medical practitioner who is highly experienced in the management of advanced liver disease and HCV treatment, according to the research. In treatment-naive and -experienced patients who experience recurrent HCV after liver transplantation, a recommended treatment regimen is a daily fixed-dose combination of ledipasvir/sofosbuvir with weight-based RBV for 12 weeks for patients with HCV genotype 1 or 4 infection in the allograft. Non genotype 1 patients who are treatment-naive and treatment-experienced with HCV genotype 2 in the allograft should undergo a daily regimen of sofosbuvir and weight-based RBV for 24 weeks.

HIV/HCV co-infection

The panel states in the research: “HIV/HCV-co-infected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications. Antiretroviral treatment interruption to allow HCV therapy is not recommended. ... Drug switches, when needed, should be done in collaboration with the HIV practitioner.”

Specific drug combinations (that may cause interactions) that providers should be mindful of in co-infected patients are ledipasvir, sofosbuvir and ledipasvir/sofosbuvir, paritaprevir/ritonavir/ombitasvir plus dasabuvir, simeprevir and RBV.

Acute HCV infection

“Infection with HCV is considered to be acute during the first 6 months,” the researchers wrote. A few recommendation from the panel for diagnosing and treating acute HCV infection include: undergoing HCV antibody and HCV RNA testing when acute HCV infection is suspected, regular laboratory monitoring until alanine aminotransferase levels are normal and HCV RNA is undetectable, and counseling to prevent transmission and other “hepatotoxic insults.”

Disclosures: Please see the full study for a list of all authors’ relevant financial disclosures.

The AASLD and IDSA HCV Guidance Panel has released updated guidelines for the treatment of hepatitis C virus infection, according to newly published data in Hepatology.

“The goal of the hepatitis C guidance is to provide up-to-date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence,” the researchers wrote. “This review provides a condensed summary of recommendations from the guidance.”

The panel, which included HCV Next Editorial board members Arthur Y. Kim, MD, and Michael R. Charlton, MD, and HCV Next Co-Chief Medical Editor Michael S. Saag, MD, used an evidence-based approach to review available information for the HCV guidance. Sources of information included peer-reviewed research; FDA research and safety information on products; manufacturer information; drug interaction data; prescribing information from FDA-approved products; and more.

Key recommendations were outlined in various topics: HCV testing and linkage to care, when and in whom to begin HCV therapy, the initial treatment of HCV, treating unique patient populations, HIV/HCV coinfection and acute HCV.

HCV testing and linkage to care

The panel recommends a one-time HCV test in people born between 1945 and 1965, as well as other people based on exposures, behaviors and conditions that may increase risk for contracting HCV. Every person that is recommended for HCV testing should be tested for anti-HCV using an FDA-approved test, according to the researchers, with positive results being confirmed through nucleic acid testing for HCV RNA. The panel also recommends annual testing be performed on men who have sex with men and people who inject drugs, as these populations are at increased risk.

Who should get HCV treatment and when

The panel recommends antiviral treatment for anyone diagnosed with chronic HCV infection, with the exception of people with limited life expectancy due to “non-hepatic causes.” If resources are limited for the patient to get treatment, the panel deems it “most appropriate to treat those at greatest risk of disease complications before treating those with less advanced disease,” according to the guidelines. To determine those at greatest risk for complications, the panel recommends noninvasive testing or liver biopsy for assessing hepatic fibrosis stage, which determines the urgency for treatment.

Top10 

Initial treatment of HCV

Treatment-naive patients with HCV and different genotypes have posed a challenge. Some of the treatment recommendations from the panel for the various genotypes remained the same, but with the approval of daclatasvir (Daklinza, Bristol-Myers Squibb), the panel recommends its use in certain situations. Daclatasvir at 60 mg in combination with sofosbuvir (Sovaldi, Gilead Sciences) has been added as recommended treatment for for treatment-naive patients with HCV genotype 1a, 1b and 3 for 12 weeks without cirrhosis and 24 weeks in combination with ribavirin in patients with cirrhosis. It is recommended in genotype 2 for 12 weeks in patients without cirrhosis.

Daclatasvir dosing should be adjusted as needed for patients with coinfection who are also receiving cytochrome P450 3A/4 inducers and inhibitors.

Retreating patients who failed prior therapy

The panel recommends various regimens for treating this type of patient population, including ledipasvir/sofosbuvir and simeprevir (Olysio, AbbVie) in combination with sofosbuvir. Treatments vary for patients with different genotypes, with and without cirrhosis, as well as patients who failed prior treatment with PEG-IFN and RBV.

Monitoring patients before, during and after antiviral therapy

The panel recommends all patients with HCV be evaluated prior to starting therapy, during treatment, and following discontinuation of treatment “in order to determine the severity of their liver disease and the efficacy and safety of their HCV treatment,” according to the research. Patients who fail to achieve sustained virologic response should undergo the following: a disease progression assessment every 6 to 12 months; ultrasound testing for HCC every 6 months in patients with advanced fibrosis; endoscopic surveillance in those with cirrhosis; among other recommendations. In patients who achieved SVR, the following is recommended: surveillance for HCC with twice-yearly abdominal imaging in those with fibrosis, patients without advanced fibrosis will no longer need to undergo additional follow-up, undergo an assessment for HCV recurrence or reinfection if the patient experiences some sort of hepatic dysfunction, among other recommendations.

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Treating unique patient populations

The panel recommends patients with decompensated cirrhosis be referred to a medical practitioner who is highly experienced in the management of advanced liver disease and HCV treatment, according to the research. In treatment-naive and -experienced patients who experience recurrent HCV after liver transplantation, a recommended treatment regimen is a daily fixed-dose combination of ledipasvir/sofosbuvir with weight-based RBV for 12 weeks for patients with HCV genotype 1 or 4 infection in the allograft. Non genotype 1 patients who are treatment-naive and treatment-experienced with HCV genotype 2 in the allograft should undergo a daily regimen of sofosbuvir and weight-based RBV for 24 weeks.

HIV/HCV co-infection

The panel states in the research: “HIV/HCV-co-infected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications. Antiretroviral treatment interruption to allow HCV therapy is not recommended. ... Drug switches, when needed, should be done in collaboration with the HIV practitioner.”

Specific drug combinations (that may cause interactions) that providers should be mindful of in co-infected patients are ledipasvir, sofosbuvir and ledipasvir/sofosbuvir, paritaprevir/ritonavir/ombitasvir plus dasabuvir, simeprevir and RBV.

Acute HCV infection

“Infection with HCV is considered to be acute during the first 6 months,” the researchers wrote. A few recommendation from the panel for diagnosing and treating acute HCV infection include: undergoing HCV antibody and HCV RNA testing when acute HCV infection is suspected, regular laboratory monitoring until alanine aminotransferase levels are normal and HCV RNA is undetectable, and counseling to prevent transmission and other “hepatotoxic insults.”

Disclosures: Please see the full study for a list of all authors’ relevant financial disclosures.